Adjunctive Vortioxetine in Schizophrenia (AVIS)

  • STATUS
    Recruiting
  • End date
    Sep 1, 2023
  • participants needed
    88
  • sponsor
    Northwell Health
Updated on 25 April 2022
benzodiazepines
antidepressants
scid
antipsychotics
structured clinical interview
cognitive symptoms
psychotic symptoms
delusions

Summary

This is a 16-week, randomized, double-blind, parallel group, placebo-controlled study comparing adjunctive vortioxetine with identically appearing adjunctive placebo pills in 88 stable patients with a research diagnosis of schizophrenia determined with the Structured Clinical Interview for DSM (SCID). Patient randomization will be stratified by illness duration (i.e., </=5 years and >5 years) in order to allow for post-hoc analyses examining whether earlier illness moderates greater negative and /or cognitive symptom reduction in response to vortioxetine.

Description

This is a 16-week, randomized, double-blind, parallel group, placebo-controlled study comparing adjunctive vortioxetine with identically appearing adjunctive placebo pills in 88 stable patients with a research diagnosis of schizophrenia determined with the Structured Clinical Interview for DSM (SCID). Patient randomization will be stratified by illness duration (i.e., </=5 years and >5 years) in order to allow for post-hoc analyses examining whether earlier illness moderates greater negative and /or cognitive symptom reduction in response to vortioxetine.

Patients with clinical stability for at least 3 months and stable antipsychotic and psychotropic medication treatment for at least the last 4 weeks and without relevant depression, positive psychotic symptoms or extrapyramidal symptoms EPS will be eligible. After written informed consent, patients will undergo a screening visit to confirm full study eligibility. If all in- and exclusion criteria are fulfilled, patients will undergo a baseline assessment and then be randomized 1:1 to 16 weeks of adjunctive treatment with vortioxetine or placebo. Subsequently, patients will be seen at week 1, 2, 4 and monthly for the next 3 months.

Details
Condition Schizophrenia, Negative Symptoms
Treatment Placebo, Vortioxetine
Clinical Study IdentifierNCT02357797
SponsorNorthwell Health
Last Modified on25 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Outpatient
SCID diagnosis of schizophrenia
Age 18-65 years old
Treated with an adequate dose of one or a maximum of two antipsychotic medications for at least 3 months, with a stable dose for at least the last 4 weeks, and willing to continue for up to 16 weeks
No antidepressant treatment for at least 8 weeks prior to randomization
Treatment with other concomitant, non-antipsychotic, psychiatric medications is allowed, but must be unchanged for at least 8 weeks, with a stable dose for at least the last 4 weeks, and willing to continue for 16 weeks. Benzodiazepines must not be given within 8 hours of the cognitive assessment. Treatment with non-psychiatric medications is unrestricted
PANSS Negative subscore >14 with at least two of the items at a level >/=4 (moderate)
PANSS Positive subscore </=14 with not more than one of the items at a level >/=4 (moderate) for patients who have been stable outpatients for <1 year. A PANSS Positive subscore of </=18 is acceptable for patients who have been stable outpatients for >/=1year and whose psychotic symptoms do not affect behavior in a clinically relevant way as per investigator assessment. - . In order to avoid simple double counting, any rating on P1 ("delusions") will not be considered as an additional symptom for determination of eligibility based on PANSS positive subscore when a specific delusion is present that is rated either on P5 ("grandiosity") or P6 ("suspiciousness/paranoia"), whereas delusions not captured by P5 ("grandiosity") or P6 ("suspiciousness/paranoia"), will be rated under P1 ("delusions") and counted toward the sum score used to determine study eligibility)
HAMD-17 total score </=12
Simpson Angus Score of any item <3
English-speaking
Competent and willing to sign informed consent

Exclusion Criteria

Structural brain disease
Mental retardation by history and estimated IQ <70 (WRAT-III Word Reading)
Autism-spectrum disorder diagnosis by history
Any serious chronic medical illnesses that in the view of the investigator will interfere with the patient's ability to comply with the study procedures or that will interfere with cognition
Active substance abuse or dependence in the past 8 weeks
Intolerance to or inefficacy of vortioxetine in the past
Acute anger to self or others as per investigator assessment
Pregnant or breastfeeding females
Unwilling or unable to be sexually abstinent or not using an effective form of birth control if they are sexually active
Current treatment with a Monoamine Oxidase Inhibitor (MAOI)
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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